Sealed capsule including an integrated puncturing mechanism

ABSTRACT

A sealed self-piercing capsule for storing and delivering a substance, such as a medicine, comprises one or more barrier layers forming a sealed chamber for containing the substance. An internal puncturing mechanism is disposed within the capsule chamber for puncturing a barrier layer to release the substance from the chamber. The internal puncturing mechanism may comprise a sharpened edge located on a movable tube, which moves relative to a barrier layer forming the sealed chamber to puncture the barrier layer.

FIELD OF THE INVENTION

The present invention relates to a delivery and packaging device forsubstances, such as medicines. The present invention is particularlyuseful for the administration of medicine by inhalation.

BACKGROUND OF THE INVENTION

Various drugs in dry powder form may be inhaled directly into the lungsthrough the mouth or nose. Inhalation allows the drug to bypass thedigestive system and may eliminate the need for other more invasive drugapplication techniques, such as hypodermic injections. Direct inhalationcan also allow smaller doses of a drug to be used to achieve the samedesired results as the same drug taken orally. Inhalation can also helpavoid certain undesirable side effects associated with taking a medicineorally or by injection.

One form of delivery device that is employed for inhaling a drug is thepressurized aerosol or metered dose inhaler (MDI). MDI's are, however,not suitable for use by all patients, e.g., small children, or for theadministration of all medicaments. In addition, MDI's use propellantsthat can cause environmental damage. A widely used alternative is theso-called dry powder inhaler in which medicament powder is dispensedfrom an elongate gelatin capsule by causing the capsule to rotate and/orvibrate in an airstream, releasing the medicament that is inhaled by thepatient. The capsules may be pierced by a suitable puncturing mechanismto release the medicament, or the capsules may be supplied inpre-pierced form. Additional packaging that prevents loss of powder fromthe capsule and the ingress of moisture is often necessary.

Gelatin capsules, and known drug delivery devices for inhalation, sufferfrom numerous disadvantages. For example, gelatin capsules are notimpervious to moisture so exposure to the atmosphere can result inabsorption of moisture. This may lead to agglomeration of the medicamentpowder particles. These problems may be particularly acute where, as isoften the case, the medicament is hygroscopic. As a result, capsulesmust be packaged in secondary packaging such as a blister package, whichsignificantly increases the overall bulk of the device. In addition, thesecondary packaging can be unwieldy or difficult to open, particularlyin an emergency situation where the medicine must be delivered as fastas possible under stressful circumstances.

Another disadvantage with the gelatin capsules is that they may becomebrittle. In this case, the piercing operation may produce shards orfragments that can be inhaled by the patient. In addition, gelatin is amaterial of biological origin and therefore often contains a certainamount of microbiological organisms, leading to possible contaminationof the medicament.

Removal of the capsule from the secondary packaging and loading it intothe device may require a degree of dexterity greater than that possessedby some patients. In addition, the motion of the elongate gelatincapsule within the device may be irregular, leading to incomplete orvariable dispensing of the powdered medicament.

Other dry powder inhaler systems use foil based drug storageconfigurations. These systems also suffer from a variety ofdisadvantages. Many foil-based systems require complex manufacturing andfilling processes. In addition, to open these foil based systems,external puncturing mechanisms, which can cause “dead spots” of trappedmedication, are normally used.

Accordingly, an object of the invention to provide a capsule fordelivery of powder or other medicaments while providing a barrier tomoisture or other unwanted material that can degrade the medicament.

Another object of the invention is to provide a system for delivering amedicament in powder or liquid form that can use such a capsule without“dead spots” or complex manufacturing and filling requirements.

These and other objects and features of the invention will be apparentfrom the described description and the figures.

SUMMARY OF THE INVENTION

The present invention meets the foregoing objects by providing a sealedcapsule with an integrated puncturing mechanism for storing anddelivering a substance, such as a medicine. The capsule has two or morebarrier layers forming a sealed chamber for containing the substance. Aninternal opening or puncturing mechanism is disposed within the capsulefor puncturing a barrier layer defining the sealed chamber from withinto release the substance from the chamber. The internal puncturingmechanism is adapted for puncturing the first chamber at a firstlocation and, possibly a second location. If two locations arepunctured, this creates an air path through the capsule.

The present invention features a sealed self-piercing capsule forstoring and delivering a medicine. The capsule has a first layer formedof a first barrier material, a second layer formed of a second barriermaterial sealed at least in part to the first layer to form a sealedfirst chamber, and a second chamber disposed within the first chamberfor holding the medicine. The second chamber is movable relative to thefirst layer and the second layers. The second chamber may include afirst edge for puncturing at least one of the first and second layers.

The capsule may have a tube forming first chamber for holding themedicine, with an access hole at a first end and a first layer ofbarrier material covering the access hole. The first layer has a firstportion that can be bonded at least in part to an outer surface of thetube and a second portion that is movable relative to the tube.

The capsule may be in the form of a tube forming a first chamber forholding the medicine which includes a first access hole at a first endand a second access hole at a second end. A first layer of barriermaterial is bonded at least in part to an outside surface of the tube,covering the first access hole and a second layer of barrier materialbonded at least in part to the outside surface of the tube, covering thesecond access hole. A sharpened edge is formed on one of the first endand the second end of the tube for puncturing one of the first layer andthe second layer. In an alternative mode, the tube may be formed ofmultiple “petals” which are closed in the first state but spread open,tearing the foil, in a second state.

The present invention also features a system for delivering a substancewith a capsule that has a barrier material forming a chamber containingan amount of a substance to be delivered. The capsule includes aninternal puncturing mechanism for opening the barrier material andreleasing the substance to be delivered. The system also contains adelivery mechanism which has a first housing component configured toreceive the capsule and an actuation mechanism for applying pressure toa first end of the capsule while the first housing component holds asecond end of the capsule in a stationary position. The application ofpressure to the first end of the capsule using the actuation mechanismcauses the internal piercing mechanism to slide within the chamber,thereby actuating the internal puncturing mechanism.

The system for delivering a substance may also be in the form of acapsule having a barrier material forming a chamber containing an amountof a substance and including an internal puncturing mechanism forpuncturing the barrier material to release the substance. The systemalso includes a delivery mechanism having a first housing component anda second housing component for housing the capsule. The second housingcomponent is movable relative to the first housing component to actuatethe internal puncturing mechanism.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 illustrates a self-piercing capsule of an embodiment of theinvention;

FIG. 2A illustrates a self-piercing capsule including an internal tubefor puncturing an outer layer of the capsule;

FIG. 2B illustrates the self-piercing capsule of FIG. 2A after openingof the capsule;

FIGS. 3A-3F illustrates embodiments a self-piercing capsule including ashoulder to facilitate actuation of the puncturing mechanism;

FIG. 4 illustrates a self-piercing capsule configured to form twoopenings on one end of the capsule;

FIG. 5 illustrates a self-piercing capsule configured to form openingson opposite ends of the capsule;

FIG. 6A illustrates a self-piercing capsule configured to form openingson opposite ends of the capsule and further including shoulders tofacilitate opening of the capsule;

FIG. 6B illustrates a delivery system including the capsule of FIG. 6A;

FIGS. 7A-7C illustrate embodiments of a self-piercing capsule thatinclude a plurality of internal chambers;

FIGS. 8A-8B illustrate a multi-dose strip of capsules;

FIG. 9 illustrates a disk containing a plurality of capsules each withdoses of medicine;

FIG. 10 illustrates a self-piercing capsule including a barrier layerbonded to a tube;

FIG. 11A illustrates a self-piercing capsule including a barrier layerbonded to a flange on a tube;

FIG. 11B illustrates a self-piercing capsule including a barrier layerbonded to a stepped outer surface on a tube;

FIG. 12 illustrates a self-piercing capsule including a barrier layerbonded to an outer surface on a tube having a plurality of access holeson one side;

FIG. 13 illustrates a self-piercing capsule including a plurality ofbarrier layers bonded to opposite ends of a tube and including anintegrated puncturing mechanism configured to form openings on oppositesides of the capsule;

FIG. 14A illustrates a self-piercing capsule including a plurality ofbarrier layers bonded to flanges formed opposite ends of a tube andincluding an integrated puncturing mechanism configured to form openingson opposite sides of the capsule;

FIG. 14B illustrates a self-piercing capsule including a plurality ofbarrier layers bonded to a stepped outer surface on an end of a tube andincluding an integrated puncturing mechanism configured to form openingson opposite sides of the capsule;

FIGS. 15A-15B illustrate a delivery system including a rotatable fan fora self-piercing capsule configured to spin within the delivery system tofacilitate release of a substance contained therein according to anembodiment of the invention;

FIG. 15C is a top view of the rotatable fan of the delivery system ofFIGS. 15A and 15B;

FIGS. 16A-16B illustrate a delivery system for implementing aself-piercing capsule configured to form fan blades for rotating thecapsule when the capsule is opened;

FIGS. 17A-17C illustrate a tube forming an inner chamber of aself-piercing capsule, the tube configured to form a plurality of fanblades when the capsule is opened;

FIGS. 18A-18B illustrate an inhaler for delivering a medicine stored ina self-piercing capsule according to another embodiment of theinvention; and

FIG. 19 illustrates an inhaler for delivering a medicine stored in aself-piercing capsule configured to open at two ends to form aflow-through air path according to another embodiment of the invention;

DETAILED DESCRIPTION OF THE INVENTION

The present invention provides an improved capsule with an integratedpuncturing mechanism for storing and delivering a substance, such asmedicine. The enhanced sealing of the capsule promotes improved deliveryof the substance by providing better protection of the substance fromthe elements, particularly if it is in the form of a powder, andimproved opening the capsule to eliminate “dead spots.”.

As used herein, the term “puncturing” refers to any form of opening,including piercing, perforating and tearing.

FIG. 1 illustrates a sealed, self-piercing capsule 100 for storing,protecting and delivering a substance, such as a medicine, suitable foruse with a delivery system, such as an inhaler. Capsule 100, as shown inFIG. 1, comprises one or more layers of a barrier material 120 forming asealed chamber 130 for holding a substance 140. The substance 140 storedin the capsule 100 can be in powder, fluid or solid form, and cancomprise a medicine, chemical, or any suitable substance that requiresprotection from degrading elements. Barrier material 120 is preferablyimpervious to one or more elements, such as moisture and/or air, thattend to degrade the substance contained with the capsule. Examples ofsuitable barrier materials are moisture-impervious materials, includingmetal foil, such as aluminum or stainless steel foils, plastics andcombinations thereof, and oxygen-impervious materials. Capsule 100further includes an internal puncturing mechanism 160 disposed withinchamber 130 for puncturing the barrier material 120 from within chamber130 to create one or more openings for releasing substance 140 fromcapsule 100.

A capsule that is impervious to degrading elements, such as moistureand/or oxygen, provides significant advantages over gelatin capsules andother types of capsules known in the art. The capsule providesprotection of the substance from moisture and/or other degrading effectswithin the capsule, without requiring secondary packaging. The sealedcapsule is preferably entirely sealed, i.e., it does not have any holes,until a user pierces or otherwise opens the capsule by actuating theinternal puncturing mechanism 160 to puncture the capsule.

In addition to providing enhanced storage and protection of thesubstance, the barrier material 120 used to form sealed capsule 100 islightweight, and not subject to the degradation which occurs in gelatincapsules. Sealed capsule 100 also has a much greater shelf life thangelatin and other prior medicine containers.

The use of an internal puncturing mechanism 160 further facilitatesrapid opening of capsule 100, while protecting the contents of thecapsule from exposure to degrading elements until actuation of internalpuncturing mechanism 160. The capsule is self-contained and does notrely on external piercing components for accessing the substance storedtherein. The internal puncturing mechanism allows opening of the capsulefrom the inside out which reduces dead spots.

FIG. 2A illustrates an embodiment of a sealed capsule 200, such as amoisture-impervious capsule for storing and delivering a medicine inpowdered form. Sealed capsule 200 comprises a plurality of barrierlayers, which can be formed of a moisture-impervious material such asfoil or plastic. The barrier layers form a chamber, and an integratedpuncturing mechanism disposed within the chamber for puncturing abarrier layer to open the capsule. Capsule 200 includes a first barrierlayer 210, such as a layer of foil, which forms a lower chamber half anda second barrier layer 220, such as layer of foil, forming an upperchamber half. First layer 210 is bonded at least in part to the secondlayer 220, such that the lower chamber half and upper chamber halfcooperate to form a hermetically sealed chamber 230 therebetween. Asshown, a seal 240 is formed about the perimeter of chamber 230 betweenthe first and second layers, which forms a sealed barrier between thechamber 230 and the ambient air.

Disposed within chamber 230 is a tube 250 defining an internal chamber252 for containing a powdered medicine 260 or other substance.Initially, tube 250 is held within the chamber 230 by friction fitbetween the outer surface of the tube and each of the barrier layers210, 220. The tube 250 can be located anywhere within chamber 230 byfriction fit and is preferably movable relative to each of the barrierlayers 210, 220. In FIG. 2A, tube 250 includes an access hole 251 forthe internal chamber 252. The lower barrier layer 220 covers the accesshole 251 and forms a powder seal against tube 250 to prevent themedicine from escaping the internal chamber 252.

In the embodiment shown in FIG. 2A, the access hole 251 comprises anopening formed in a first end of the tube 250. Alternatively, the tube250 may be substantially closed at the first end and include a pluralityof openings forming the access hole 251. Similarly, the access hole 251may comprise one or more openings formed in the sidewall of the tube 250in the vicinity of the first end. For example, the access hole 251 maycomprise a plurality of holes formed about the perimeter of the tube 250near the first end.

The tube 250 shown in FIG. 2A includes an integrated puncturingmechanism for puncturing one of the barrier layers to form an openingfor releasing the medicine from the capsule 200. The illustratedpuncturing mechanism comprises a sharpened edge 253 formed on the bottomedge of the tube 250. The sharpened edge 253 may be continuous about thebottom perimeter of tube 250, or may comprise one or more discrete edgesformed at one or more locations on the tube. The puncturing mechanism isnot limited to a sharpened edge and can comprise any suitable means,such as a chemical means, for puncturing one or more of barrier layersfrom the interior of the capsule or otherwise opening the capsule.

Tube 250 is slidable within the chamber 230 relative to the first layer210 and the second layer 220, to actuate the puncturing mechanism toopen the chamber 252. For example, as shown in FIGS. 2A and 2B, a barrel280, which forms part of a delivery system for housing the capsule anddelivering the substance contained therein, pushes against the lowerlayer 220 of the capsule 200 while pressure is applied to the oppositeend of the capsule 200. Barrel 280 deforms the lower layer 220 to forcelower layer 220 against the sharpened edge 253 of tube 250. One skilledin the art will recognize that any suitable device for pushing the lowerlayer 220 and/or the upper layer relative to the tube 250 may be used,and that the invention is not limited to the illustrative deliverysystem.

The barrel 280 shown in FIGS. 2A and 2B has an inner diameter configuredto receive the lower end of capsule 200, though barrel 280 can have anysuitable size and configuration. Barrel 280 and/or lower layer 220 areconfigured such that the coefficient of friction between the barrel 280and the lower layer 220 is higher than the coefficient of frictionbetween tube 250 and the lower layer 220. As a result, as barrel 280moves toward the capsule 200, barrel 280 pushes the lower layer 220against the sharpened edge 253 of tube 250. As barrel 280 continues tomove forward, tube 250 moves within chamber 230 and toward lower layer220, which causes the sharpened edge 253 to contact and puncture lowerlayer 220, thereby opening the capsule 200.

After puncturing the capsule 200, tube 250 pushes through the openingcreated by sharpened edge 253 and holds the punctured portion 220A ofthe lower layer 220 against the inner surface of barrel 280. As aresult, the access hole 251 is maintained in an open position,facilitating the release of the medicine from within the capsule. Theuse of tube 250 to hold the punctured portion 220A of the capsuleagainst the inner surface of the barrel also prevents shards of thepunctured lower layer from traveling and being inhaled by a user. Thepunctured portion may be completely cut away from the lower layer 220,or may remain connected to the lower layer 220 through a non-puncturedportion.

Capsule 200 thus protects and preserves the medicine, while providingeasy release of the medicine by a user.

Lower layer 220 and/or barrel 280 may be configured to facilitatesliding of lower layer 220 relative to tube 250 to facilitate puncturingof the lower layer. For example, as shown in FIG. 3A, the lower layer220 may include a shoulder 228 that surrounds at least a portion of theperimeter of tube 250. Shoulder 228 may be continuous about the entireperimeter of tube 250, or may comprise one or more discrete structuresformed in lower layer 220. Shoulder 228 is configured to receive the topedge 281 of the barrel 280. Barrel 280 is sized and dimensioned to slideover lower portion of the lower layer 220, and abut shoulder 228. Topedge 281 of barrel 280 pushes against the shoulder 228 to push lowerlayer 220 past the sharpened edge 253 of the tube to puncture thecapsule.

The shoulder can have any suitable geometry and is not limited to ashoulder that extends perpendicular to the tube 250. For example, theshoulder may be curved, angled or have any suitable configuration forabutting barrel 280. The shoulder may alternately be provided as aseparate component, such as a ring attached around lower layer 220.Examples of alternate embodiments of shoulder 228 are shown in FIGS.3B-3F. As shown in FIG. 3B, a shoulder 228C of a capsule can be slightlyrounded. As shown in FIG. 3C, a shoulder 228C can be curved. As shown inFIG. 3D, a shoulder 228D may extend at an angle from the side of thecapsule. As shown in FIG. 3E, a shoulder 228E can extend at an anglefrom the top of a capsule. As shown in FIG. 3F, a shoulder 228F canextend at a small angle relative to a tube 250 of the capsule. Oneskilled in the art will be able to determine a suitable configurationand size of a shoulder in a capsule having an integrated puncturingmechanism.

Alternatively, barrel 280 may be modified to increase the frictionbetween lower layer 220 and barrel 280 to facilitate movement of lowerlayer 220 relative to tube 250 and thereby to facilitate puncturing ofthe lower layer. The inner surface of the barrel can be textured, orinclude protrusions or other features for gripping the lower layer toenhance the actuation of the puncturing mechanism.

Barrel 280 can also be advanced over the capsule end to puncture thecapsule through a twisting action. For example, barrel 280 can includethreads on the inner surface that engage with a protrusion formed onlower layer 220. As the barrel rotates, the threads engage theprotrusion and advance the barrel, pushing the lower layer relative totube 250. Alternatively, another threaded piece (not shown) is situatedon the other side of the capsule that would engage barrel 280 and serveto force the capsule toward barrel 280 as the barrel is rotated.

The internal puncturing mechanism of the sealed capsule of the presentinvention may be configured to puncture the exterior layers of thecapsules in a plurality of locations to create an air path through thecapsule. For example, as shown in FIG. 4, tube 250 may include a firstsharpened edge 253A and a second sharpened edge 253B for puncturinglower layer 220 in two different locations. The first punctured locationforms an inlet to chamber 252, while the second punctured location canform an outlet for chamber 252. An airflow can be induced throughchamber 252 to facilitate discharging of the medicine. In the embodimentof FIG. 4, first sharpened edge 253A and second sharpened edge 253B areeach formed on a hollow tubular protrusion 254A, 254B, respectively,extending from chamber 252 toward lower layer 220. One skilled in theart will recognize that multiple inlets and/or multiple outlets may beformed to facilitate airflow through the capsule interior.

By creating an air path through the capsule, the puncturing mechanismreduces the dead volume of the capsule to ensure that the medicine doesnot get trapped within chamber 230. The use of the internal puncturingmechanism provides a clean access hole through the barrier material fromthe inside out, which eliminates the edges or other causes of “deadspots”, ensuring that all of the medication stored in the capsule can bedelivered. In addition, providing multiple openings provides a betterairflow path and also helps to facilitate complete removal of themedicine from the capsule. The openings may further be designed todisperse the substance, for example a powder, as air moves through thechamber 252 by creating a vortex or turbulence.

In FIG. 4, tube 250 forms a flange 259 that is complementary to ashoulder 228 formed in the lower layer. Flange 259 limits travel of thetube relative to the first and second layers and/or the barrel 280,though tube 250 can also be formed without flange 259 and the capsulecan be formed without shoulder 228.

Alternatively, the internal puncturing mechanism may be configured topuncture the capsule at opposite ends to create a flow-through air paththrough the capsule interior. For example, as shown in FIG. 5, tube 250includes a second sharpened edge 257 on the end opposite the firstsharpened edge 253 for puncturing the top layer 210 of the capsule. Asshown, tube 250 may include a second access hole 254 formed at a secondend of the tube 250. Prior to actuation of the puncturing mechanism, thesecond access hole 254 may be covered by the top layer 210 to seal thechamber 252. A second barrel 290 is provided for sliding the top layer210 relative to tube 250, while first barrel 280 is used, as describedabove, to slide lower layer 220 relative to tube 250. As the barrelspush against the capsule from opposite sides, tube 250 moves relative toboth the upper and lower layers, such that first sharpened edged 253punctures lower layer 220 and second sharpened edge punctures upperlayer 210.

As shown in FIG. 6A, a capsule 610 configured to open on two oppositeends may also include shoulders 227, 228 formed in the first and secondlayers, respectively, about the perimeter of the tube 250 to facilitatemovement of the tube relative to the two layers and thereby actuate apuncturing mechanism. In the embodiment of FIG. 6A, the tube alsoincludes an annular protrusion 258 formed on at least a portion of theouter perimeter of tube 250. Annular protrusion 258 is configured totrap the first shoulder and/or the second shoulder to limit the traveldistance of tube 250 relative to the barrier layer. Alternatively, thebarrel can include a protrusion or other stop means for limiting thetravel of tube 250.

FIG. 6B illustrates the capsule 610 of FIG. 6A in a delivery system 600,comprising a first barrel 280 and a second barrel 290. The first barreland the second barrel cooperate to receive the capsule 610, such that asurface 292 of upper barrel 290 abuts the upper shoulder 227 of thecapsule and a surface 282 of lower barrel 280 abuts the lower shoulder228 of the capsule. As shown, lower barrel 280 may be configured toreceive the upper barrel 290, for example, by having an outer wall 285that has a diameter that is slightly larger than an outer wall 295 ofthe upper barrel. The upper barrel and the lower barrel also includeinner tubular portions 283, 293, respectively, configured to receive acorresponding end portion of the barrel. Inner tubular portions 283, 293preferably have an inner diameter that is slightly larger than the outerdiameter of tube 250.

To open the capsule, pressure is applied to each barrel from oppositeends to push the barrels together. As the barrels are pushed together,surface 292 of the upper barrel pushes against shoulder 227 of topbarrier layer 210, while surface 282 of the lower barrel pushes againstshoulder 228 of lower barrier layer 220. The pressure applied to uppershoulder 227 causes top barrier layer 210 to move relative to tube 250.Top barrier layer 210 approaches the second sharpened edge 257 on thetop side of the tube. As the barrel continues to move top barrier layer210, the second sharpened edge 257 punctures the top barrier layer andpushes the tube through the resulting opening. Similarly, lower barrel280 pushes lower barrier layer 220 until the lower sharpened edge 253punctures lower barrier layer 220 and pushes the lower end of tube 250through the resulting opening. Annular protrusion 258 forms a stop forlimiting the travel of the barrels and preventing tube 250 and barrierlayers 210, 220 from further movement. After actuation of the puncturingmechanism, tube 250 maintains an open air path through the capsule bypushing the punctured portions of the barrier layers against theinterior wall of the respective barrel.

The capsule can be used with a delivery system, such as an inhaler. Thereleased medicine can be inhaled directly through or from the storagechamber without having to transfer the medicine to another chamber fordispensing.

As shown in FIGS. 7A-7C, a capsule 710 may comprise a plurality ofconnected tubes 250A, 250B forming inner chambers 252A, B. The innerchambers 252A, 252B may be sealed and separate from each other, as shownin FIGS. 7B and 7C, or may be connected, as shown in FIG. 7A. The use ofmultiple chambers allows different substances to be stored and deliveredtogether.

As shown in FIGS. 8A and 8B, a plurality of single-dose capsules 200 maybe provided together in a strip 800. Strip 800 comprises a plurality ofdiscrete tubes 250 and an integrated top barrier layer 2100 and a bottombarrier layer 2200 connecting tubes 250.

As shown in FIG. 9, a plurality of doses of a medicine, where each doseis stored in a tube 250, can be provided as a disk 900.

FIG. 10 illustrates another embodiment of a sealed capsule 400 includingan integrated puncturing mechanism. Capsule 400 includes a tube 450forming a chamber 430 for holding medicine or another substance therein.Tube 450 includes an access hole 451 on the first end, which is coveredby a layer 420 of a barrier material, such as a moisture-imperviousmaterial. A portion of barrier material 420 is bonded, at least in part,to the outside surface of tube 450 to form a seal 440 about theperiphery of the tube. The seal 440 hermetically seals the chamber 430from the outside environment to protect the substance contained thereinfrom exposure to damaging elements. The remainder of the barriermaterial 420 is not bonded to tube 450 and is movable relative to tube450. Capsule 400 includes an integrated puncturing mechanism,illustrated as a sharpened edge 454 formed on the first end of the tube,for puncturing layer 420 to open the capsule 400. The sharpened edge 454punctures barrier material 420 when the unbonded portion of the materialslides past the end of tube 450.

According to one aspect of the invention, at least a portion of the tubecan be formed of a transparent material to allow a user to view thecontents of chamber 430. Having a transparent portion or window allowsthe user to see if the drug has been contaminated or clumped beforeinhalation, thereby minimizing some potential problems common with manyinhalers. Similarly, the user can see if all of the medication has beendispensed by viewing through the window post-inhalation.

Barrel 480 may be used to actuate the puncturing mechanism by moving theunbonded portion of barrier material 420 relative to tube 450. As thebarrel pushes the unbonded portion of barrier material 420, sharpenededge 454 advances toward the material 420. The sharpened edge 454punctures and pushes through the material 420 to open chamber 430.

As shown in FIGS. 11A and 11B, the barrier material 420 can be bonded toa protrusion on tube 450, which also serves to limit the travel ofbarrel 480. For example, as shown in FIG. 11A, the barrier material canbe bonded to a flange 455 extending about the perimeter of tube 450.After puncturing of the barrier layer, the flange forms a stop for thetop edge 481 of the barrel to prevent the capsule from sliding throughthe barrel interior.

Alternatively, as shown in FIG. 11B, the tube may include a lowersection 450A having a first diameter, a second section 450B having asecond, larger diameter, and a step 450C connecting the first and secondsections. The barrier material is bonded to the second section 450B, andthe step is configured to limit the travel of the barrel 480, which hasan inner surface configured to interface with the capsule outer surface.In addition to limiting the travel of barrel 480, step 450C provides abonding surface for the foil.

In the embodiments of FIGS. 11A and 11 b, barrier layer 420 forms ashoulder 448 to facilitate sliding of the unbonded portion relative tothe tube, though the capsule can alternatively be formed without theshoulder.

Sealed capsule 400 may also be configured to be punctured in a pluralityof locations to create a flow path through the tube. For example, asshown in FIG. 12, tube 450 may include a plurality of access holes 451,452 on one side. Tube 450 is similar to the embodiment shown in FIG. 4,and includes a plurality of edges 453A, 453B for puncturing the barrierlayer in the vicinity of the access holes to open the capsule. While theembodiment of FIG. 12 shows the barrier layer bonded to an outer surfaceof tube 450, the barrier layer can also bond to a flange or otherprotrusion on the outer surface of the tube, as described above. Thebarrier layer can also include a shoulder or other suitableconfiguration for facilitation sliding of the unbonded portion relativeto the tube to puncture the barrier layer.

Alternatively, the puncturing mechanism may be configured to createopenings on opposite ends of the sealed capsule, as shown in FIG. 13.For example, the capsule shown in FIG. 13 includes a first access hole451 formed on a first end of tube 450, and a second access hole 454formed on a second end of the tube. First access hole 451 is covered bya first barrier layer 410, which bonds at least in part to the outsidesurface of tube 450 to form a first seal 440A. The second access hole452 is covered by a second barrier layer 420, which bonds at least inpart to the outside surface of the tube to form a second seal 440B. Thefirst and second seals form a hermetically sealed chamber 430 withintube 450. Tube 450 also includes a first sharpened edge 454 formed alongat least a portion of the perimeter of first access hole 451 forpuncturing the first barrier layer. Tube 450 also includes a secondsharpened edge 458 formed along at least a portion of the perimeter ofsecond access hole 452 for puncturing the second barrier layer.

The unbonded portion of first barrier layer 410 is movable relative totube 450 to facilitate puncturing of the capsule. The unbonded portionof second barrier layer 420 may also be movable relative to tube 450 tofacilitate puncturing of the capsule. To puncture capsule 400 to releasea substance contained within chamber 430, an upper barrel 490 pushesagainst first barrier layer 410 to push the unbonded portion of firstbarrier layer 410 against sharpened edge 454, while the bonded portionof first barrier layer 410 is held stationary against the tube outersurface. The upper barrel 490 moves the unbonded portion of firstbarrier layer 410 until the sharpened edge punctures the first barrierlayer to create an opening. Barrel 490 may continue to push firstbarrier layer 410 past the sharpened edge to push tube 450 through theresulting opening. Similarly, a lower barrel 480 pushes the unbondedportion of second barrier layer 420 toward second sharpened edge 458 tocause the second sharpened edge to puncture and create an opening insecond barrier layer 420. The puncturing of the first and second barrierlayers may occur simultaneously or at separate times.

One of ordinary skill in the art will recognize that the delivery systemis not limited to the described barrels, and that any suitable means canbe used to house and/or actuate the puncturing mechanism. For example,the user could actuate a puncturing mechanism by pushing directly on oneof the barrier layers with his fingers to slide the puncturing mechanismrelative to the barrier layer in order to puncture the capsule.

As described above, the use of a plurality of different sharpened edgesto create a plurality of openings in a capsule create an air paththrough the capsule to facilitate release of the substance containedtherein.

As shown in FIGS. 14A and 14B, one or both of the barrier layers can bebonded to a protrusion, flange or other feature on the outer surface oftube 450. For example, as shown in FIG. 14A, upper barrier layer 410 maybe bonded to an upper flange 472 and lower barrier layer 420 may bebonded to a lower flange 474. The flanges may form a stop for limitingthe travel distance of tube 450 relative to the barrels and the barrierlayers. The portion of the tube between the flanges may form a window475 to allow a user to view the contents of the chamber 430. Forexample, tube 450 or a portion of the tube between the flange may beformed of a transparent material to create the window.

In FIG. 14B, the end portions 450A, 450B of tube 450 have a diameterthat is reduced relative to the central portion 450C. A step 450D, 450Econnects the central portion 450C to each of the end portions 450A,450B, respectively. Steps 450D, 450E also form stops for limiting thetravel of the barrels relative to tube 450.

In the embodiments of FIGS. 14A and 14B, the upper and lower barrierlayers further include shoulders 448, 449, respectively, to facilitatemovement of the unbonded portion relative to the tube, though thecapsule can also be formed without the shoulder or using other means tofacilitate movement of the unbonded portion relative to the tube. Thebarrier layers may alternatively be bonded to opposite sides of acentral flange or protrusion on tube 450.

A plurality of capsules 400 or chambers 450 may be provided together asa strip or a disk to provide a multi-dose package. The different dosesmay be linked by the barrier material, or by the material forming thetube, for example, by flanges extending from each of the tubes.

In many of the embodiments of the invention, the capsule including anintegrated puncturing mechanism may be configured to spin about acentral axis to facilitate ejection of the substance from the capsule.For example, after puncturing of the barrier material, the capsule canspin to eject medicine from therein and cause the medicine to beentrained in airflow to be inhaled by the user.

FIGS. 15A and 15B illustrate a delivery system 1500 including a capsule1510 having an integrated puncturing mechanism that is configured tospin about a central axis to facilitate ejection of a medicine from thecapsule after puncturing of the capsule. As shown, the capsule 1510comprises a tube 1550 defining an inner chamber 1552 for containing amedicine or other substance. The tube 1550 includes one or more accessholes 1551 for providing access to the inner chamber 1552. The accessholes 1551 are shown as being formed in the side wall of the tube 1550at an upper end of the tube. The capsule 1510 further includes a barriermaterial 1520 bonded at least in part to the tube 1550 and covering theaccess holes 1551 to seal the chamber 1552. The chamber 1552 may have aconical shape, as shown, to facilitate ejection of the medicine throughthe access holes 1551 when the capsule spins about a longitudinal axis.

In the illustrative embodiment, the barrier material 1520 is bonded to aflange 1555 formed on the tube 1550, though one skilled in the art willrecognize that the barrier material 1520 can be bonded to any suitablelocation or component of the tube 1550.

The capsule 1510 further includes an integrated puncturing mechanism,which comprises a sharpened edge 1553 formed about the perimeter of theupper end of the tube in the embodiment shown in FIGS. 15A and 15B.

The capsule 1510 is configured to be disposed in a delivery system 1500comprising a mouthpiece 1582, a holder 1584, a plunger 1586 and a radialfan 1588. The radial fan 1588, which fits inside the mouthpiece 1582,forms a ring that surrounds the top end of the capsule 1510 when thedelivery system 1500 is assembled. The plunger, which fits inside theholder 1584, forces the capsule 1510 against the radial fan. To open thecapsule, as shown in FIG. 15B, the user pushes the mouthpiece 1582 andthe holder 1584 together. As the mouthpiece 1582 moves toward the holder1584, the mouthpiece pushes the radial fan 1588 against the plunger1586. The radial fan 1588 contacts and pushes against the barriermaterial 1520, which deforms the barrier material and causes the barriermaterial to slide against the internal puncturing mechanism, i.e., thesharpened edge 1553, to open the capsule.

FIG. 15C is a cross-sectional top view of the radial fan 1588. As shown,the radial fan 1588 comprises a central ring 1592 configured to receivethe upper end of the capsule 1510. Fan blades 1594 extends about thecircumference of the radial fan to cause rotation of the fan when airpasses past the fan 1588. Fluted air vents 1589 provide an air paththrough the radial fan to allow air flow from the holder to themouthpiece.

At the same time, or shortly thereafter, the user inhales air throughthe mouthpiece 1582 to create an air flow through the inhaler. As airmoves through the inhaler, fluted blades on the radial fan 1588 causethe radial fan to spin, which in turn causes the capsule 1510 to spin.As the capsule spins, centrifugal force acts on the substance in thechamber 1552 to expel the substance out of the chamber through thenow-opened access holes 1551. The blades of the radial fan 1588, inaddition to inducing the spinning of the capsule, further break up thesubstance to facilitate inhalation of the substance by the user. Theinhaler body can also include fluted air vents to help direct air flowonto the fan blades to cause the rotation.

The capsule 1510 can also be configured to open in a plurality oflocations to allow air flow through the capsule, which can facilitatethe expulsion of the substance in addition to the centrifugal force.

In an alternate embodiment, a capsule including an integrated puncturingmechanism can be configured to form a plurality of fan blades when thecapsule opens to facilitate release of the substance stored therein.FIGS. 16A and 16B illustrate a delivery system 1600 suitable for usewith a capsule 1610 including integrated fan blades. The capsule 1610includes a tube 1650 forming an internal chamber 1652 for containing asubstance. A barrier material 1620 covers the tube 1650, including a tophole 1651 of the tube 1650, to seal the capsule. The delivery system1600 includes a mouthpiece 1682, a holder 1684, an anvil 1686 coupled toand movable relative to the mouthpiece 1682 and a plunger 1688 forpushing a capsule 1610 disposed within the delivery system 1600 againstthe anvil 1686.

To open the capsule 1610, the user pushes the mouthpiece 1682 toward theholder 1684, which pushes the anvil 1686 into the top hole 1651 andagainst the barrier material 1620 of the capsule 1610. As the anvil 1686pushes against the barrier material 1620, sharpened edges on the tube1650 puncture the barrier material 1620 to open the capsule. The anvilcontinues to press against the capsule to spread blades 1650 a, 1650 bforming the tube 1650 open. The spreading of the blades 1650 a, 1650 bopens the capsule by piercing and tearing the barrier material 1620.

As shown in FIGS. 17A-17C, the tube 1650 comprises a plurality of hingedblades 1650 a-1650 h, connected to a bottom surface 1654. One or more ofthe blades includes a sharpened upper edge 1653 for puncturing thebarrier material 1620. FIG. 17A illustrates the tube 1650 defining theinternal chamber 1652 of the capsule 1610 when the capsule is in aclosed, sealed position. FIG. 17B illustrates the tube 1650 in asemi-opened position, when the blades 1650 a-1650 h are slightly spread.In the fully opened position, shown in FIG. 17C and FIG. 16B, the blades1650 a-1650 h form fluted air vents, which allow the substance to escapethe capsule. As a user inhales air through the mouthpiece, the generatedairflow causes the blades to rotate, thus rotating the capsule about alongitudinal axis. Alternatively, the blades 1650 a-1650 h serve only toopen the capsule, and other fan blades, for example fan blades on aradial fan, such as the radial fan of FIG. 15C can be used to effectrotation of the capsule 1610.

The rotation of the capsule facilitates the release and entrainment ofthe substance in the airflow and creates a vortex effect to facilitatedelivery of the substance to the user. Alternatively, the capsule can beconfigured to form flutes in the barrier material upon puncturing of thecapsule, which can act as fan blades to induce rotation of the capsule.Alternatively, the capsule and/or barrier material can be manufacturedwith integral fan blades to facilitate rotation, rather than forming thefan blades during the puncturing process.

In the embodiments of FIGS. 15-17, the self-piercing capsule includingthe integrated puncturing mechanism spins within a delivery system tofacilitate delivery of a substance using air flow generated by a user.Alternatively, a mechanical device, such as a motor, may be used to spinthe capsule to facilitate delivery of a substance contained in thecapsule.

FIGS. 18A and 18B illustrate an inhaler suitable for implementing acapsule including an internal puncturing mechanism according to theinvention. The inhaler 1800 comprises a housing 1880 forming amouthpiece 1882 and including an air inlet 1884 opposite the mouthpiece1882. The mouthpiece 1882 can alternatively be configured to be insertedor interface with a user's nasal passage for inhalation via the nose.The housing 1880 forms an air path between the inlet and the mouthpiece.The housing 1880 is configured to hold a capsule 1810 containing asubstance and including an internal puncturing mechanism. As shown, thehousing holds the capsule 1810 in a position such that an air paththrough the punctured capsule intersects the air path through thehousing 1880.

Capsule 1810 is similar to the capsule shown in FIG. 11A, except theaccess holes 1851 are formed in a side wall of the tube 1850 definingthe capsule chamber 1852 for holding the substance. The capsule 1810includes a barrier material 1820 covering the access holes 1851. Aportion of the barrier material 1820 is bonded in part to the tube 1850to seal the capsule chamber 1852, while an unbonded portion is movablerelative to the tube 1850. Tube 1850 includes a sharpened edge 1853formed on a lower end thereof to facilitate opening of the capsule 1810.As shown, the barrier material 1820 forms a shoulder 1811 to facilitatesliding of the barrier material 1820 past the sharpened edge 1853 topuncture the barrier material.

The housing 1880 includes a capsule hole 1883 sized and dimensioned toreceive the capsule, an upper protrusion 1885 on an inner surface of thehousing surrounding the capsule hole for receiving the flange of thecapsule, and a lower protrusion 1887 configured to abut the shoulder1811 of the capsule 1810 to hold the capsule 1810 within the housing.

When the user presses against the upper end of the capsule 1810, asshown in FIG. 18B, the capsule 1810 moves within the housing toward thelower protrusion 1887. The lower protrusion 1887 presses against theshoulder 1811 to prevent movement of the barrier material 1820, whileallowing the tube 1850 to slide relative to the barrier material. As thecapsule is pressed into the bottom of the housing 1880, the barriermaterial 1820 buckles, and the sharpened edge of the capsule 1810punctures the barrier material. The punctured portion 1820A of thebarrier material 1820 forms a disk in the shape of the sharpened edge1851, which is trapped between the capsule and the housing 1880.

As shown in FIG. 18B, after puncturing of the capsule 1810, the accessholes 1851 of the capsule align with air vents 1889 on the lowerprotrusion 1887 to allow the substance to escape the capsule.Alternatively, the air vents 1889 are provided in fluid communicationwith the access holes 1851 to provide an air path between the air inlet1884 and the mouthpiece 1882 through the punctured capsule 1810. As theuser inhales through the mouthpiece 1882, drawing air into the housinginterior via the air inlet and through the capsule 1810 via the accessholes 1851, the air vents 1889 direct the airflow through the capsule todisperse the powder into the inhaled air for delivery to the user.

FIG. 19 illustrates another delivery system suitable for implementing acapsule having an integrated puncturing mechanism. The delivery system1900 is suitable for use with a capsule 1910 comprising an open-endedtube 1950 covered on each side by a barrier material 1910, 1920, forexample as shown in FIG. 14A. Delivery system 1900 includes a firsthousing component, illustrated as a mouthpiece 1982, and a secondhousing component 1984 coupled to the first housing component. Deliverysystem 1900 also includes a threaded cap 1986 surrounding the secondhousing component 1984 and including threads 1986 a on an inner surfacethereof for engaging threads on an outer surface of the mouthpiece 1982.The capsule 1910 is disposed in a chamber 1985 formed by the housingcomponents, such that the first barrier material 1910 abuts an innersurface of the mouthpiece 1982 and the second barrier material 1920abuts an inner surface of the second housing component. As shown in FIG.19, the capsule is held within the chamber 1985 via friction fit.

To actuate the inhaler and open capsule 1910, the threaded cap 1986 istwisted to force the mouthpiece 1982 and the second housing component1984 closer together. As the mouthpiece 1982 and second housingcomponent 1984 move closer together, each housing component pushes theadjacent barrier material 1910, 1920 relative to the tube 1950, causingsharpened edges 1951, 1952 on each end of the tube 1950 to puncture thebarrier material 1910, 1920 to create a flow through air path throughthe capsule 1910. The user inhales through the mouthpiece 1982 to pullthe substance within the capsule into the user's lungs.

The mouthpiece 1982 can be configured for a user's mouth or nose, sothat the user can inhale the substance through the mouth or nose inthis, and all other embodiments of the invention.

In the delivery system of FIG. 19, one of the housing components,illustrated as the mouthpiece 1982 includes a transparent window 1989aligned with a transparent portion of the capsule 1910 to allow the userto view the substance to ensure complete delivery of the substance tothe user.

The sealed capsule of the present invention provides significantadvantages not seen in the prior art. The capsule provides a sealed,protected environment for a substance and prevents exposure of thesubstance from degrading elements for an extended period of time. Forexample, the capsule can provide a moisture-impervious environment formoisture-sensitive substances, such as medicines in powdered form. Theuse of an integrated, internal puncturing mechanism facilitates releaseof the substance from the capsule without relying on externalcomponents. The puncturing mechanism may be easily actuated, forexample, by sliding the puncturing mechanism (i.e., the tube) within theinternal chamber of the capsule. The components of the sealed capsuleare designed for manufacturability and the capsule may be assembled andfilled quickly and efficiently. The integrated puncturing mechanism ofthe invention provides a clear, unobstructed path for the substancestored in the capsule to exit and reduces the number of dead spots oredges that trap the substance, a feature common in capsules that utilizeexternal puncturing mechanisms. Moreover, the ability to create an airpath through an internal chamber of a capsule using an integratedpuncturing mechanism allows direct delivery of the substance from thecapsule, without requiring transfer of the substance to a separatedelivery chamber. The integrated puncturing mechanism facilitatescomplete evacuation of all of the substance from the capsule interior,resulting in more accurate dosing, increased safety and reduced waste.

The present invention has been described relative to illustrativeembodiments. Since certain changes may be made in the aboveconstructions without departing from the scope of the invention, it isintended that all matter contained in the above description or shown inthe accompanying drawings be interpreted as illustrative and not in alimiting sense.

It is also to be understood that the following claims are to cover allgeneric and specific features of the invention described herein, and allstatements of the scope of the invention which, as a matter of language,might be said to fall therebetween.

The invention claimed is:
 1. A capsule adapted for storing anddelivering a dose, comprising a first layer formed of a barriermaterial; a second layer formed of a barrier material sealed at least inpart to the first layer to form a sealed first chamber; and a secondchamber adapted for holding the dose disposed within the first chamberand movable relative to said first layer and said second layer, whereinthe second chamber includes a first edge for puncturing the first layer;wherein a portion of the first layer surrounds at least a portion of thefirst edge.
 2. The capsule of claim 1, wherein the second chambercomprises a first access hole at a first end that is covered by thefirst layer.
 3. The capsule of claim 2, wherein the second chamberincludes a second access hole at a second end that is covered by thesecond layer.
 4. The capsule of claim 3, wherein the first layer and thesecond layer form a seal surrounding a perimeter of the second chamber.5. The capsule of claim 4, wherein the portion of the first layer thatsurrounds a portion of the first edge includes a first shoulder.
 6. Thecapsule of claim 5, wherein the second layer includes a second shoulderabout at least a portion of the perimeter of the second chamber betweenthe seal and the second end of the second chamber.
 7. The capsule ofclaim 6, wherein the second chamber includes an annular protrusionextending about at least a portion of the perimeter of the secondchamber, wherein the annular protrusion is configured to trap one ofsaid first shoulder and said second shoulder.
 8. The capsule of claim 1,wherein the first layer forms a first shoulder about at least a portionof a perimeter of the second chamber.
 9. The capsule of claim 8, whereinthe second layer forms a second shoulder about at least a portion of aperimeter of the second chamber.
 10. The capsule of claim 1, wherein thesecond chamber includes a second edge for puncturing one of the firstlayer and the second layer to create an air path through the capsule.11. The capsule of claim 10, wherein the first edge is formed on a firstside of said second chamber proximate to the first layer and the secondedge is formed on a second side of the second chamber opposite saidfirst side for puncturing the second layer.
 12. The capsule of claim 10,wherein said first edge and said second edge are formed on a first sideof the second chamber for puncturing the first layer at two distinctlocations.
 13. A capsule adapted for storing and dispensing a dose,comprising: a first layer formed of a barrier material; a second layerformed of a barrier material bonded to the first layer to form a sealedfirst chamber; an internal puncturing mechanism within the sealed firstchamber adapted for puncturing the first sealed chamber at first andsecond locations to create an air path through the capsule; and a secondchamber disposed within the first chamber, wherein the puncturingmechanism is formed on said second chamber.
 14. The capsule of claim 13,wherein the second chamber is slidable within the first chamber toactuate the puncturing mechanism.
 15. The capsule of claim 13, whereinthe puncturing mechanism comprises a first sharpened edge and a secondsharpened edge.
 16. The capsule of claim 15, wherein the first sharpenededge is located on a first end of the second chamber to puncture thefirst layer and the second sharpened edge is located on a second end ofthe second chamber opposite the first end to puncture the second layer.17. The capsule of claim 15, wherein the first sharpened edge and thesecond sharpened edge are both located on a first end of the secondchamber.
 18. The capsule of claim 17, wherein the first sharpened edgeand the second sharpened edge each comprise a hollow tubular protrusionextending from the second chamber toward the first layer.
 19. Thecapsule of claim 13, wherein the first layer forms a first shoulderabout at least a portion of a perimeter of the second chamber.
 20. Thecapsule of claim 19, wherein the second layer forms a second shoulderabout at least a portion of a perimeter of the second chamber.
 21. Thecapsule of claim 20, wherein the second chamber includes an annularprotrusion extending about at least a portion of the perimeter of thesecond chamber, wherein the annular protrusion is configured to trap oneof said first shoulder and said second shoulder.
 22. A capsule adaptedfor storing and delivering a dose, comprising a chamber having wallsadapted for holding dose therein, the chamber having a first accesshole; a first layer of a barrier material that covers the first accesshole and that conforms to an outer surface of the chamber about thefirst access hole to retain dose therein; and a first edge of thechamber movable relative to said first layer to puncture the first layerto adapt the capsule for dispensation of dose from the chamber throughthe access hole.
 23. The capsule of claim 22, wherein the chamber has asecond access hole and a barrier material that covers the second accesshole.
 24. The capsule of claim 23, wherein the chamber includes a secondedge movable relative to said second layer to puncture the second layer.25. The capsule of claim 22, further comprising a second layer ofbarrier material, wherein the first layer and the second layer form aseal surrounding a perimeter of the chamber.
 26. The capsule of claim22, further comprising a second layer of barrier material, wherein thefirst layer and the second layer define a second chamber.
 27. Thecapsule of claim 23, wherein the first access hole and the second accesshole are positioned on opposite sides of the chamber.
 28. The capsule ofclaim 1, in combination with the dose.
 29. The capsule of claim 28,wherein the dose includes powdered medicament.
 30. The capsule of claim13, in combination with the dose.
 31. The capsule of claim 30, whereinthe dose includes powdered medicament.
 32. A device adapted for storingand delivering a dose, comprising a chamber adapted for storing a doseand defining a first end and a second end opposed to the first end, thefirst end including an opening; a first barrier layer that covers theopening at the first end; and a cutter internal to the chamber, thecutter attached to the first barrier layer at the first end of thechamber and adapted to rupture the first barrier layer when urged in adirection toward the first barrier layer to allow dose to be deliveredfrom the chamber.
 33. A device adapted for storing and delivering adose, comprising a chamber adapted for storing a dose and defining afirst end and a second end opposed to the first end, the first endincluding an opening; a first barrier layer that covers the opening atthe first end; and a cutter internal to the chamber that is adapted torupture the first barrier layer when urged in a direction toward thefirst barrier layer to allow dose to be delivered from the chamber;wherein the first barrier layer is adjacent to and conforms to surfacesof the cutter at positions about the opening.
 34. The device of claim32, wherein the chamber is formed at least in part by a second barrierlayer.
 35. The device of claim 34, wherein the first and second barrierlayers are bonded together.
 36. The device of claim 35, in combinationwith a barrel that receives and cooperates with the cutter to cut apunctured portion of the first barrier layer from remaining portions ofthe first barrier layer.
 37. The device of claim 35, wherein the cutteris bonded directly to the first barrier layer, and has a portion thatextends to, and is bonded to, the second end of the chamber.
 38. Adevice adapted for storing and delivering a dose, comprising: a sealedfirst chamber that is adapted for holding the dose, the sealed firstchamber including a first layer of a barrier material; a dose located inthe sealed first chamber; and an internal puncturing mechanism withinthe sealed first chamber adapted for puncturing the first sealedchamber, the puncturing mechanism including an edge arranged tocompletely cut a punctured portion of the first layer from remainingportions of the chamber.
 39. The device of claim 38, wherein the firstlayer includes a shoulder formed to surround the edge of the puncturingmechanism.
 40. The device of claim 38, wherein the puncturing mechanismis bonded to the first layer.
 41. The device of claim 38, wherein thesealed first chamber includes a second layer of a barrier materialbonded to the first layer.
 42. The device of claim 38, in combinationwith a barrel that receives and cooperates with the internal puncturingmechanism to cut the punctured portion of the first layer from remainingportions of the chamber.
 43. A device adapted for storing and deliveringa dose, comprising: a sealed first chamber that is adapted for holdingthe dose, the sealed first chamber including a first layer of a barriermaterial; a dose located in the sealed first chamber; and an internalpuncturing mechanism within the sealed first chamber adapted tocooperate with a barrel to puncture the first layer, the puncturingmechanism being bonded to the first layer.
 44. The device of claim 43,in combination with a barrel that receives and cooperates with theinternal puncturing mechanism to cut the punctured portion of the firstlayer from remaining portions of the chamber.
 45. The device of claim43, wherein the first layer includes a shoulder formed to surround aportion of the puncturing mechanism.
 46. The device of claim 43, whereinthe sealed first chamber includes a second layer of a barrier materialbonded to the first layer.